Label: DR ANDREW WEILS FOR ORIGINS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45- titanium dioxide and zinc oxide lotion

  • NDC Code(s): 59427-113-01
  • Packager: ORIGINS NATURAL RESOURCES INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 11, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    titanium dioxide 6.3%Sunscreen
    zinc oxide 4.0%Sunscreen
  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children.
    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    • apply generously and evenly 15 minutes before sun exposure
    • reapply at least every two hours
    • use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10am – 2pm
      • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
  • Inactive ingredients

    water\aqua\eau • dimethicone • butyloctyl salicylate • c12-15 alkyl benzoate • methyl trimethicone • isononyl isononanoate • diethylhexyl succinate • neopentyl glycol diheptanoate • butylene glycol • dipentaerythrityl tri-polyhydroxystearate • lauryl peg-9 polydimethylsiloxyethyl dimethicone • silica • citrus aurantium dulcis(orange) peel oil 1, pelargonium odorata flower oil 1, eugenia caryophyllus (clove) bud oil 1, rosa damascena flower oil 1, jasminum officinale (jasmine) oil 1, viola odorata flower/leaf extract, polianthes tuberosa extract, geraniol, benzyl benzoate, citronellol, eugenol • epilobium angustifolium flower\leaf\stem extract • hordeum vulgare (barley) extract\extrait d'orge • triticum vulgare (wheat) germ extract • vaccinium angustifolium (blueberry) fruit extract • vaccinium macrocarpon (cranberry) fruit extract • lycium chinense (wolfberry) fruit extract • rosa roxburghii fruit extract • opuntia tuna extract • trimethylsiloxysilicate • hydroxyapatite • cetyl peg/ppg-10/1 dimethicone • glycerin • scutellaria baicalensis root extract • squalane • yeast extract\faex\extrait de levure • dimethicone/peg-10/15 crosspolymer • dimethicone silylate • tocopheryl acetate • hydrolyzed wheat protein/pvp crosspolymer • dimethicone crosspolymer-3 • isostearic acid • caprylyl glycol • polyhydroxystearic acid • bht • phenoxyethanol <iln41804>


    1
    essential oil
  • Other information

    protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

    Dr. Andrew
    WEIL
    for Origins™

    Mega-Defense
    SPF 45

    Advanced Daily
    UV Defender
    Broad Spectrum SPF 45

    1 fl. oz./oz. liq./30 ml e

    Principal Display Panel - 30 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DR ANDREW WEILS FOR ORIGINS  MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE63 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    CLOVE OIL (UNII: 578389D6D0)  
    ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    VIOLA ODORATA FLOWERING TOP (UNII: 04BPC87I4H)  
    GERANIOL (UNII: L837108USY)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    EUGENOL (UNII: 3T8H1794QW)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    BARLEY (UNII: 5PWM7YLI7R)  
    WHEAT GERM (UNII: YR3G369F5A)  
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    SQUALANE (UNII: GW89575KF9)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59427-113-011 in 1 CARTON02/15/2016
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/15/2016
    Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(59427-113) , pack(59427-113) , label(59427-113)